Knee Arthritis Clinical Trial
— PAKAOfficial title:
Can Periarticular Knee Injection of Multimodal Agents Levobupivicaine, Morphine, Ketorolac and Adrenaline Improve Postoperative Pain and Function Following Primary Total Knee Arthroplasty?
Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.
Status | Completed |
Enrollment | 46 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial. Exclusion Criteria: - Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment). - Those patients who lack capacity under the Mental Capacity Act 2005 - Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury. - Those patients having spinal anaesthesia. - Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy. - Haemorrhagic diatheses, including coagulation disorders - Hypersensitivity to ketorolac trometamol or other NSAIDs - Moderate or severe renal impairment (serum creatinine > 160 micromol/l) - Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients - Uncontrolled angina - 2nd/ 3rd degree heart block |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Warwick, University House, | Coventry |
Lead Sponsor | Collaborator |
---|---|
University of Warwick |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale | A validated, patient-reported 100 mm visual analogue pain score. It is a line 100mm long on which patient places a line through to mark the severity of the pain the patient is experiencing from 0mm= No pain to 100mm wost pain possible. | 18 Hours post operatively | No |
Secondary | 4 point pain score | An ordinal 4-point pain score recorded every six hours by an independent nurse during the first 48 hrs after the surgery. | First 48 hours post surgery | No |
Secondary | Analgesia required | The total use of "as required" analgesia in the first 48hrs after the operation | 48 hour period post operativley | No |
Secondary | Concentration of Levobupivicaine in drain and patient serum samples | The concentration of local anaesthetic agent (Levobupivicaine) in the drain fluid collected in the Bellovac ABT and patient serum concentrations. The drain concentration will be assessed at 6 hrs post operation with serum concentrations pre-retransfusion (tourniquet- down time + 40 mins) and post-retransfusion (post-op + 6hrs 40min). | 6 hours post operation and pre and post retransfusion | No |
Secondary | Functional Assessments change over time 18, 48 & 6 weeks | The patients 'straight-leg raise' and mobilisation will be assessed by an independent physiotherapist on the ward after the surgery and a more formal functional assessment of the knee will be made at 6 weeks using the Oxford Knee Score: a validated, patient-reported measure of knee function. | 18 & 48 Hours and 6 weeks post surgery | No |
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